Category Archives: Glucose Monitoring

Medtronic Expands 630G/670G Pump Recall; Xeris Completes Acquisition of Strongbridge; DreaMed FDA Clearance for AI-based Clinical Decision Support System for T2DM; Know Labs Bio-RFID Readings Comparable to FDA-Cleared Devices

A series of cardiometabolic-related news items have been observed: Medtronic recalled 600 series insulin pumps (view FDA website); Xeris announced the closing of its acquisition of Strongbridge BioPharma; DreaMed announced FDA clearance of its AI-based clinical decision support system, called Advisor Pro, for patients with T2DM; Know Labs published a report that shows the accuracy of its non-invasive Bio-RFID technology blood glucose sensor is comparable to FDA-cleared devices (press release; view report). Below, FENIX provides further highlights and insights for the respective news items.  Medtronic expands 630G/670G pump recall Medtronic recently recalled an expanded set of its 600 series insulin pumps (630G and 670G)……

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Lilly Presents SURPASS-3 CGM and MRI Sub-studies; Insulet Omnipod 5 Extension Study Results; Onduo Collaborates with Fitbit; EASD 2021 Key Press Releases (Sept 30)

On the fourth day of EASD 2021, four key press releases were observed from Lilly, Insulet, and Onduo. Below FENIX provides insights and context from each respective announcement.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Nemaura Launches New Metabolic Health Program; Biocon Receives More Form 483 Observations; Virta Health Key Leadership Appointments; Dexcom G6 Coverage in Manitoba; EASD 2021 Key Press Releases (Sept 29)

On the third day of EASD 2021, four key press releases were observed from Nemaura, Biocon, Virta Health, and Dexcom. Below FENIX provides insights and context for the respective announcements.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lilly Cuts Non-branded Lispro Prices By 40%; Positive Ph1 Data for New GLP-1RA Asset; Lifescan Presents Tu Salud Trial Data in Hispanic Population; EASD 2021 Key Press Releases (Sept 28)

On the second day of EASD 2021, three key press releases were observed from Lilly, Altimmune, and Lifescan. Below FENIX provides insights and context for the respective announcements.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocorp and Novo Mallya Partnership; Nemaura Signs Contract for Non-invasive CGM EU Distribution; AHA Late-breaking Science Sessions Released; EASD 2021 Key Press Releases (Sept 27)

On the first day of EASD 2021, two key press releases were observed from Biocorp and Nemaura Medical. Additionally, AHA late-breaking science sessions have been released. Below FENIX provides insights and context from each respective announcement, including thoughts on how the Biocorp/Novo Nordisk partnership could signal Novo’s disposable connected pen solution is further behind than previously anticipated.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

New Non-invasive BGM; Amarin Updates Vascepa US Go-to-market Strategy; Welldoc Receives 510(k) Clearance for Bolus and Premixed Insulin Titration; CinFina Agreement with Janssen for QW Obesity Assets

A series of cardiometabolic-related news items have recently been observed: Know Labs announced the addition of KnowU, a portable Bio-RFID glucose monitoring device, to the company’s portfolio of non-invasive diagnostic technology; Amarin announced an update to its Vascepa go-to-market strategy, including US field force layoffs; Welldoc announced FDA 510(k) clearance for the BlueStar Insulin Adjustment Program for bolus and premixed insulin titration; and CinFina Pharma announced an agreement with Janssen Sciences Ireland Unlimited Company to acquire exclusive WW rights to four QW anorectic agents for the treatment fo obesity. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Diamyd’s Ph3 T1DM Vaccine Placed on Partial Clinical Hold; Osama Hamdy Joins Nemaura Scientific Board; Medtronic Licenses Implantable Pump; Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors

A series of cardiometabolic-related news items have been observed: Diamyd’s Ph3 has been placed on partial clinical hold (press release); Nemaura announced Osama Hamdy joined the company’s advisory board (press release); Medtronic licenses implantable insulin pump from the Alfred E. Mann Foundation (press release); Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors (press release). Below, FENIX provides highlights and insights from the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Oral Sema Ph3 Obesity Program Initiated; GlucoModicum Appoints Former Dexcom Exec; Lilly Contributes to T1DM Camp Initiative

A series of cardiometabolic-related news items have recently been observed: a Novo Nordisk trial evaluating oral semaglutide in adults with obesity, called OASIS 1, has been observed on CT.gov; GlucoModicum announced the appointment of Peter Gerhardsson to Senior Advisor; and Lilly announced a commitment of nearly $1M donation over the next three years, in conjunction with the Helmsley Charitable Trust, to support a T1DM Camp Initiative. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Gvoke Kit Receives FDA Approval; Medtronic Q2 ’21 Earnings Update

Two diabetes news items have been observed: Xeris announced FDA approved the sNDA for Gvoke Kit (1mg/0.2 mL single-dose vial syringe kit); and Medtronic hosted its CY Q2 ’21 (FY Q1 ’22) earnings call. Below, FENIX provides highlights and insights from the Medtronic call as well as thoughts on how Xeris’s decision to develop the Gvoke Kit was likely influenced by the channel mix.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lyumjev Approved for Insulin Pump Use; Dario and Nemaura Q2 ’21 Earnings Updates; CHMP Agenda August 16-19

A series of cardiometabolic-related news items have been observed: Lilly announced FDA approved Lyumjev for pump compatibility; Dario hosted its Q2 ’21 earnings call (press release); Nemaura Medical published its CY Q2 ’21 (FY Q1 ’22) business update (press release); and the CHMP agenda for this month’s meeting (August 16-19) has been released. Below, FENIX highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.